Phase 2 N=28 Randomized Quadruple-blind Treatment

Mild Encephalopathy in the Newborn Treated With Darbepoetin

Neonatal Encephalopathy · Hypoxic-Ischemic Encephalopathy Mild

Bottom Line

View on ClinicalTrials.gov: NCT03071861 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Normal Neurodevelopment — 13; 14 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Darbepoetin Alfa (Drug); Normal Saline (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of New Mexico
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Normal Neurodevelopment	13; 14	—
SECONDARY Percent of Infants With Adverse Events	0; 0	—
SECONDARY Percent of Infants With Seizures	0; 0	—
SECONDARY Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home	0; 0	—

Summary

This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat neurologic examination at less than six hours of age. Participants will be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth. Neurodevelopmental testing (Bayley (III or IV) and Gross Motor Function Assessment) will be performed at 24 months of age. Pharmacokinetics will be assessed on those infants that received Darbe.

Eligibility Criteria

Inclusion Criteria: Infants will be eligible for the MEND trial if they have a gestational age > 34 weeks by best obstetric estimate, are 65%, platelet count >600,000/dL, and/or neutropenia (ANC<500 μL)

ECMO
Infant judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03071861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.